79. 家族性高コレステロール血症(ホモ接合体) [臨床試験数:128,薬物数:105(DrugBank:29),標的遺伝子数:8,標的パスウェイ数:15

Searched query = "Homozygous familial hypercholesterolemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
49 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04659863
(ClinicalTrials.gov)
January 29, 20212/12/2020Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial HypercholesterolemiaTwo Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Homozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-13)Homozygous Familial HypercholesterolemiaDrug: Inclisiran;Drug: PlaceboNovartis PharmaceuticalsNULLNot yet recruiting12 Years17 YearsAll12Phase 3NULL
2NCT03851705
(ClinicalTrials.gov)
February 6, 20197/2/2019A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (Hofh) (ORION-5)Homozygous Familial HypercholesterolemiaDrug: Inclisiran for injection;Drug: PlacebosNovartis PharmaceuticalsNULLActive, not recruiting18 Years80 YearsAll56Phase 3Hong Kong;Israel;Russian Federation;Serbia;South Africa;Taiwan;Turkey;Ukraine;Czechia
3JPRN-JapicCTI-184099
30/9/201820/08/2018STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EVINACUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIAA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EVINACUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA Homozygous familial hypercholesterolemia (HoFH)Intervention name : Evinacumab
INN of the intervention : Evinacumab
Dosage And administration of the intervention : INTRAVENOUS Injection
Control intervention name : PLACEBO
INN of the control intervention : -
Dosage And administration of the control intervention : INTRAVENOUS Injection
Regeneron Pharmaceuticals, Inc.(ICCC: PAREXEL International)NULLcomplete18BOTH57NAJapan, North America, Europe, Oceania, Africa
4EUCTR2017-001388-19-DE
(EUCTR)
18/06/201823/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Regeneron Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
57 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
5EUCTR2017-001388-19-GR
(EUCTR)
02/05/201802/04/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 21.0;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
65Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-001388-19-AT
(EUCTR)
23/03/201830/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
7NCT03399786
(ClinicalTrials.gov)
January 18, 20188/1/2018Efficacy and Safety of Evinacumab in Patients With Homozygous Familial HypercholesterolemiaA Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaDrug: evinacumab;Drug: PlaceboRegeneron PharmaceuticalsNULLCompleted12 YearsN/AAll65Phase 3United States;Australia;Austria;Canada;France;Greece;Italy;Japan;Netherlands;South Africa;Ukraine;Czechia;Germany;Turkey
8EUCTR2017-000351-95-DE
(EUCTR)
13/12/201717/08/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 3France;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy
9EUCTR2017-000351-95-GR
(EUCTR)
08/11/201719/10/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3Germany;France;United States;Czech Republic;Canada;Greece;Ukraine;Turkey;Austria;South Africa;Italy
10NCT03156621
(ClinicalTrials.gov)
October 3, 201715/5/2017Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Alirocumab in Patients With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaDrug: Alirocumab;Drug: PlaceboRegeneron PharmaceuticalsSanofiCompleted18 YearsN/AAll69Phase 3United States;Austria;Canada;Czechia;France;Germany;Greece;Italy;Japan;South Africa;Taiwan;Turkey;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-000351-95-AT
(EUCTR)
03/10/201722/08/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Regeneron Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
54 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Greece;Canada;Ukraine;Turkey;Austria;South Africa;Germany;Italy
12EUCTR2017-000351-95-FR
(EUCTR)
18/07/201723/06/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
54Phase 3United States;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Italy;France;Denmark;South Africa;Tunisia;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
13EUCTR2015-004003-23-IT
(EUCTR)
28/09/201627/05/2016A controlled study to assess the safety, tolerability and activity of the study drug ISIS 703802 given subcutaneously to Healthy Volunteers with high triglycerides and patients with Familial HypercholesterolemiaA Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ISIS 703802, Targeting ANGPTL3, Administered Subcutaneously to Healthy Volunteers with Elevated Triglycerides andSubjects with Familial Hypercholesterolemia Heterozygous familial hypercholesterolemia and Homozygous familial hypercholesterolemia
MedDRA version: 19.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850
MedDRA version: 19.0;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;Classification code 10057079;Term: Heterozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ISIS 703802
Product Code: ISIS 703802
INN or Proposed INN: ISIS 703802
Other descriptive name: ISIS 703802
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
61Phase 1;Phase 2Canada;Netherlands;Italy
14NCT02434497
(ClinicalTrials.gov)
June 6, 20157/4/2015A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial HypercholesterolemiaAn Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH)Homozygous Familial Hypercholesterolemia (HoFH)Drug: Rosuvastatin 20mgAstraZenecaNULLCompleted6 Years18 YearsAll9Phase 3Belgium;Canada;Denmark;Israel;Malaysia;Taiwan
15EUCTR2014-004856-68-NO
(EUCTR)
29/04/201526/01/2015A 12-week, open-label , all subjects will first receive 2 weeks of placebo drug and then active medication in a dose escalating manner: each patient will first receive 50 mg, after evaluation the option exists to increase the dose to to 100 mg and after another evaluation to 200 mg active study drug, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH)A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) Homozygous Familial Hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: MBX-8025
Product Code: MBX-8025
INN or Proposed INN: MBX-8025
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
8Phase 2France;Netherlands;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-004856-68-NL
(EUCTR)
23/04/201528/01/2015A 12-week, open-label , all subjects will first receive 2 weeks of placebo drug and then active medication in a dose escalating manner: each patient will first receive 50 mg, after evaluation the option exists to increase the dose to to 100 mg and after another evaluation to 200 mg active study drug, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH)A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) Homozygous Familial Hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: MBX-8025
Product Code: MBX-8025
INN or Proposed INN: MBX-8025
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
8Phase 2France;Norway;Netherlands
17NCT02472535
(ClinicalTrials.gov)
April 201522/5/2015Study to Evaluate the Effects of MBX-8025 in Patients With HoFHA 12-week, Open-label, Dose-escalating, Phase 2 Study to Evaluate the Effects of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)Homozygous Familial HypercholesterolemiaOther: Run-In Period: Placebo;Drug: MBX-8025 50 mg (Dose Escalation Period 1);Drug: MBX-8025 50 mg or 100 mg (Dose Escalation Period 2);Drug: MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3)CymaBay Therapeutics, Inc.NULLCompleted18 YearsN/ABoth13Phase 2Canada;France;Netherlands;Norway
18EUCTR2014-004746-99-DK
(EUCTR)
27/03/201527/03/2015A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).
MedDRA version: 19.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
19EUCTR2014-004856-68-FR
(EUCTR)
13/03/201519/05/2015A 12-week, open-label , all subjects will first receive 2 weeks of placebo drug and then active medication in a dose escalating manner: each patient will first receive 50 mg, after evaluation the option exists to increase the dose to to 100 mg and after another evaluation to 200 mg active study drug, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH)A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH) Homozygous Familial Hypercholesterolemia;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: MBX-8025
Product Code: MBX-8025
INN or Proposed INN: MBX-8025
CymaBay Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
8Phase 2France;Norway;Netherlands
20EUCTR2014-004746-99-BE
(EUCTR)
23/02/201518/12/2014A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-000972-24-DK
(EUCTR)
17/12/201425/09/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.0;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Germany;Netherlands;Sweden
22EUCTR2014-000972-24-DE
(EUCTR)
17/11/201426/09/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Denmark;Australia;South Africa;Germany;Netherlands;Norway;Sweden
23NCT02226198
(ClinicalTrials.gov)
November 201414/8/2014A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial HypercholesterolemiaA Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (Aged 6 to <18 Years) With Homozygous Familial Hypercholesterolemia (HoFH)Homozygous Familial Hypercholesterolemia (HoFH)Drug: Rosuvastatin 20mg;Drug: PlaceboAstraZenecaNULLCompleted6 Years17 YearsAll20Phase 3Belgium;Canada;Denmark;Israel;Malaysia;Netherlands;Taiwan;Germany;Lebanon;Sweden;United States
24EUCTR2014-000972-24-BE
(EUCTR)
27/10/201411/09/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25Phase 3United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden
25EUCTR2014-000972-24-NL
(EUCTR)
20/10/201405/08/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2014-000972-24-SE
(EUCTR)
20/08/201430/06/2014A study to evaluate the effect of Rosuvastatin on fatty acids in Children and Adolescents with Homozygous Familial HypercholesterolemiaA Randomized, Double blind, Placebo controlled, Multi center, Cross over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) - HYDRA Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 17.1;Level: LLT;Classification code 10054380;Term: Familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Crestor Tablets (calcium rosuvastatin) Film-Coated tablets
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: calcium rosuvastatin
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
25United States;Taiwan;Hong Kong;Israel;United Kingdom;Czech Republic;Belgium;Australia;Denmark;South Africa;Germany;Netherlands;Norway;Sweden
27EUCTR2011-005399-40-NL
(EUCTR)
24/09/201303/07/2013A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Homozygous familial hypercholesterolaemia
MedDRA version: 16.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
Other descriptive name: AMG 145
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
59Phase 2/3United States;Hong Kong;Spain;Lebanon;Turkey;Italy;France;Czech Republic;Canada;Brazil;Belgium;Malaysia;South Africa;Netherlands;New Zealand
28EUCTR2012-002434-37-IT
(EUCTR)
16/07/201305/06/2013n.a.A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-WeekStudy to Assess the Efficacy and Tolerability of Anacetrapib When Added to OngoingLipid-Lowering Therapy in Adult Patients with Homozygous FamilialHypercholesterolemia (HoFH) - n.a. Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 14.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Anacetrapib
Product Code: MK-0859
INN or Proposed INN: ANACETRAPIB
Other descriptive name: ANACETRAPIB
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
45Phase 3United States;Czech Republic;Canada;Malaysia;Brazil;Israel;South Africa;Norway;United Kingdom;Italy
29EUCTR2011-005399-40-ES
(EUCTR)
24/06/201309/04/2013A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Homozygous familial hypercholesterolaemia
MedDRA version: 14.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
INN or Proposed INN: n/a
Other descriptive name: AMG 145
Amgen IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
67Phase 2/3United States;Hong Kong;Spain;Turkey;Austria;France;Czech Republic;Canada;Belgium;Brazil;Malaysia;South Africa;New Zealand
30EUCTR2012-002434-37-CZ
(EUCTR)
13/06/201328/12/2012n/aA Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-WeekStudy to Assess the Efficacy and Tolerability of Anacetrapib When Added to OngoingLipid-Lowering Therapy in Adult Patients with Homozygous FamilialHypercholesterolemia (HoFH) with a 52-Week Open-Label Extension Homozygous Familial Hypercholesterolemia (HoFH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: MK-0859
Product Code: (4S,5R)-5-[3,5-bis(trifluoromethyl)phenyl]-3-{[4’-
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
45United States;Czech Republic;Canada;Malaysia;Australia;Israel;South Africa;Norway;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2011-005399-40-IT
(EUCTR)
08/06/201323/04/2013A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Homozygous familial hypercholesterolaemia
MedDRA version: 14.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
INN or Proposed INN: NA
Other descriptive name: AMG 145
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
67Phase 2/3United States;Hong Kong;Spain;Turkey;Austria;Italy;France;Czech Republic;Canada;Belgium;Brazil;Malaysia;South Africa;Netherlands;New Zealand
32NCT01841684
(ClinicalTrials.gov)
June 201324/4/2013Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Lipid-Lowering Therapy in Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)Hyperlipoproteinemia Type II;Homozygous Familial HypercholesterolemiaDrug: Anacetrapib;Drug: PlaceboMerck Sharp & Dohme Corp.NULLTerminated18 YearsN/ABoth2Phase 3United States;Canada;Germany;Israel;Italy;United Kingdom;Norway
33EUCTR2012-002434-37-GB
(EUCTR)
23/05/201323/11/2012n/aA Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Lipid-Lowering Therapy in Adult Patients with Homozygous Familial Hypercholesterolemia (HoFH) with a 52-Week Open-Label Extension - Anacetrapib in Patients with Homozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia (HoFH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot Recruiting Female: yes
Male: yes
45 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Malaysia;Australia;Israel;South Africa;Norway;Italy;United Kingdom
34EUCTR2011-005399-40-CZ
(EUCTR)
03/05/201326/02/2013A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Homozygous familial hypercholesterolaemia
MedDRA version: 16.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
Other descriptive name: AMG 145
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
59Phase 2;Phase 3United States;Hong Kong;Spain;Lebanon;Turkey;Italy;France;Czech Republic;Canada;Brazil;Belgium;Malaysia;South Africa;Netherlands;New Zealand
35EUCTR2012-002434-37-NO
(EUCTR)
21/11/201226/11/2012n/aA Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-WeekStudy to Assess the Efficacy and Tolerability of Anacetrapib When Added to OngoingLipid-Lowering Therapy in Adult Patients with Homozygous FamilialHypercholesterolemia (HoFH) with a 52-Week Open-Label Extension Homozygous Familial Hypercholesterolemia (HoFH);Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: MK-0859
Product Code: (4S,5R)-5-[3,5-bis(trifluoromethyl)phenyl]-3-{[4’-
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
45United States;Czech Republic;Canada;Malaysia;Australia;Israel;South Africa;Norway;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT01588496
(ClinicalTrials.gov)
April 5, 201227/2/2012Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaBiological: Evolocumab;Drug: PlaceboAmgenNULLCompleted12 Years80 YearsAll58Phase 2/Phase 3United States;Belgium;Canada;Czechia;France;Hong Kong;Italy;Lebanon;Netherlands;New Zealand;South Africa;Spain;Czech Republic
37EUCTR2011-005399-40-BE
(EUCTR)
09/03/201207/02/2012A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Homozygous familial hypercholesterolaemia
MedDRA version: 14.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
Other descriptive name: AMG 145
Amgen IncNULLNot RecruitingFemale: yes
Male: yes
59Phase 2;Phase 3United States;Hong Kong;Spain;Lebanon;Turkey;Italy;France;Czech Republic;Canada;Malaysia;Belgium;Brazil;South Africa;Netherlands;New Zealand
38EUCTR2005-003449-15-GB
(EUCTR)
12/07/200709/03/2007A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia SubjectsA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 as Add-on Therapy in Homozygous Familial Hypercholesterolemia Subjects - RADICHOL I Reduction of low density lipoprotein C (LDL-C) in Homozygous Familial Hypercholesterolemia (HoFH)
MedDRA version: 9.1;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia
Genzyme Europe B.V.NULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
39NCT00607373
(ClinicalTrials.gov)
July 200722/1/2008Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial HypercholesterolemiaA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Mipomersen as Add-on Therapy in Homozygous Familial Hypercholesterolemia SubjectsLipid Metabolism, Inborn Errors;Hypercholesterolemia, Autosomal Dominant;Hyperlipidemias;Metabolic Diseases;Hyperlipoproteinemia Type II;Metabolism, Inborn Errors;Genetic Diseases, Inborn;Infant, Newborn, Diseases;Metabolic Disorder;Congenital Abnormalities;Hypercholesterolemia;Hyperlipoproteinemias;Dyslipidemias;Lipid Metabolism DisordersDrug: mipomersen;Drug: PlaceboKastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Completed12 YearsN/AAll51Phase 3United States;Brazil;Canada;Singapore;South Africa;Taiwan;United Kingdom;Netherlands
40EUCTR2005-003626-26-GB
(EUCTR)
14/06/200601/11/2005A double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of TAK-475 or placebo when co-administered with current lipid-lowering therapy in subjects with homozygous familial hypercholesterolemiaA double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of TAK-475 or placebo when co-administered with current lipid-lowering therapy in subjects with homozygous familial hypercholesterolemia Treatment of primary dyslipidemia
MedDRA version: 8;Level: PT;Classification code 10058108
Product Name: TAK-475
Product Code: TAK-475
Takeda Europe R&D Centre LtdNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00263081
(ClinicalTrials.gov)
November 20056/12/2005Efficacy of Lapaquistat Acetate Co-Administered With Current Lipid-Lowering Treatment on Blood Cholesterol Levels in Subjects With Homozygous Familial HypercholesterolemiaA Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 or Placebo When Co-administered With Current Lipid-lowering Therapy in Subjects With Homozygous Familial Hypercholesterolemia.HypercholesterolemiaDrug: Lapaquistat acetate and current lipid-lowering treatment;Drug: Current lipid-lowering treatmentTakedaNULLTerminated8 YearsN/ABoth44Phase 3United States;Canada;France;Israel;Poland;United Kingdom
42NCT00079846
(ClinicalTrials.gov)
September 200317/3/2004Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering TherapySafety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering TherapyFamilial HypercholesterolemiaDrug: ImplitapideMedical Research Laboratories InternationalNULLTerminated8 Years70 YearsBoth60Phase 2United States;Canada;Israel;Netherlands;Norway
43NCT03884452
(ClinicalTrials.gov)
May 3, 20006/3/2019Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial HypercholesterolemiaFamilial HypercholesterolemiaDrug: Atorvastatin;Drug: Simvastatin;Drug: Ezetimibe;Drug: Placebo for EzetimibeMerck Sharp & Dohme Corp.NULLCompleted12 YearsN/AAll50Phase 3NULL
44EUCTR2020-002755-38-NL
(EUCTR)
26/12/2020Study to evaluate efficacy and safety of inclisiran in adolescents with homozygous familial hypercholesterolemiaTwo part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with homozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-13) Homozygous Familial Hypercholesterolemia
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: inclisiran sodium
Product Code: KJX839
INN or Proposed INN: inclisiran
Other descriptive name: Inclisiran sodium
Novartis Pharma AGNULLNAFemale: yes
Male: yes
12Phase 3France;United States;Serbia;Slovenia;Greece;Canada;Lebanon;Turkey;Netherlands;Switzerland
45EUCTR2017-001388-19-CZ
(EUCTR)
01/02/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Evinacumab (REGN1500)
Product Code: REGN1500
INN or Proposed INN: Evinacumab
Other descriptive name: EVINACUMAB
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
57Phase 3United States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2011-005399-40-Outside-EU/EEA
(EUCTR)
17/12/2014A clinical study to assess the safety, tolerability and efficacy of AMG 145 in subjects with homozygous familial hypercholesterolemiaA two part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability, and Efficacy of AMG 145 in Subjects With Homozygous Familial HypercholesterolemiaPart B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia - TESLA Homozygous familial hypercholesterolaemia
MedDRA version: 17.1;Level: LLT;Classification code 10057100;Term: Homozygous familial hypercholesterolaemia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: AMG 145
Product Code: AMG 145
INN or Proposed INN: EVOLOCUMAB
Amgen IncNULLNAFemale: yes
Male: yes
59Phase 2/3South Africa;Turkey;United States;Brazil;Canada;Hong Kong;Lebanon;Malaysia;New Zealand
47EUCTR2014-004746-99-SE
(EUCTR)
23/12/2014A study to evluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.An Open-Label Long-Term Extension to the Randomized, Double-blind, Placebo-controlled, Multi-center, Cross-over Study of Rosuvastatin in Children and Adolescents (aged 6 to <18 years) with Homozygous Familial Hypercholesterolemia (HoFH) Hypercholesterolemia - The current trial will study children with Homozygous Familial Hypercholesterolemia (HoFH).;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Crestor Film-Coated Tablet
Product Name: Crestor
Product Code: ZD4522
INN or Proposed INN: Rosuvastatin calcium
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
20Phase 3United States;Taiwan;Canada;Malaysia;Belgium;Lebanon;Denmark;Israel;Netherlands;Germany;Sweden
48EUCTR2017-001388-19-FR
(EUCTR)
24/01/2018A study to evaluate the safety and efficacy of evinacumab in patients with Hereditary abnormal (high) cholesterol levelA randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of evinacumab in patients with homozygous familial hypercholesterolemia Homozygous familial hypercholesterolemia
MedDRA version: 20.1;Level: LLT;Classification code 10020604;Term: Hypercholesterolemia;System Organ Class: 100000004861 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Regeneron Pharmaceuticals Inc.NULLNA Female: yes
Male: yes
57 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Ukraine;Turkey;Austria;Italy;France;Czech Republic;Canada;Australia;South Africa;Germany;Netherlands
49EUCTR2017-000351-95-CZ
(EUCTR)
28/07/2017A study to the safety and efficacy of alirocumab in patients with Hereditary abnormal (high) cholesterol levelA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALIROCUMAB IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA - ODYSSEY HoFH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
MedDRA version: 20.0;Level: LLT;Classification code 10057080;Term: Homozygous familial hypercholesterolemia;System Organ Class: 100000012386;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Praluent
INN or Proposed INN: ALIROCUMAB
Other descriptive name: ALIROCUMAB
Regeneron Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
54Phase 3Serbia;Portugal;United States;Slovenia;Greece;Spain;Ukraine;Turkey;Austria;Israel;Italy;United Kingdom;Czech Republic;Canada;Poland;Belgium;Croatia;Denmark;South Africa;Bulgaria;Netherlands;Germany;Tunisia;Sweden